Apparatus and method for positive closure of an internal tissue membrane opening

ABSTRACT

The invention provides a device having two components: a needle advancing apparatus slidable longitudinally along a catheter to advance needles into a tissue membrane, such as a blood vessel wall, around an opening in the membrane; and, a suture retrieval assembly insertable through the catheter beyond a distal side of the tissue membrane. The needle advancing apparatus advances suture through the tissue wall. The suture retrieval assembly grabs the suture on the distal side of the tissue membrane for extraction thereof through the opening in the tissue membrane. A method for suturing a membrane beneath the patient&#39;s skin is also disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 10/008,781filed Nov. 13, 2001, now U.S. Pat. No. 7,060,078 which is a continuationof application Ser. No. 09/553,267, filed Apr. 20, 2000, now U.S. Pat.No. 6,348,059; which is a continuation of application Ser. No.09/158,446 filed Sep. 22, 1998 now U.S. Pat. No. 6,132,440, which is acontinuation of application Ser. No. 08/935,848 filed Sep. 23, 1997 nowU.S. Pat. No. 5,810,850, which is a continuation of application Ser. No.08/465,765, filed Jun. 6, 1995 now U.S. Pat. No. 5,720,757, which is acontinuation of application Ser. No. 08/194,072 filed Feb. 9, 1994 nowU.S. Pat. No. 5,476,469, which is a continuation of application Ser. No.07/963,053 filed Oct. 19, 1992 now U.S. Pat. No. 5,304,184, all of whichare hereby incorporated by reference in their entirety.

BACKGROUND OF THE INVENTION

The present invention relates generally to an apparatus and method forclosure, such as by suturing, of tissue membrane openings. The presentinvention has particular application in the closure of openings in bloodvessel walls after catheterization procedures in the cardiovascularsystem have been performed.

A wide variety of techniques have been employed to provide nonsurgical,less invasive procedures in a medical patient. These includelaparoscopy, arthroscopy, and various other techniques in which surgicaland/or medicational procedures are performed via tubes, such ascatheters, rather than full-scale “cut down” surgery. One such techniqueis the Seldinger technique involving the placement of guide wires andcatheters in the cardiovascular system of the patient. Although suchnonsurgical procedures typically greatly enhance the recovery time ofthe patient when compared to more conventional cut down surgery,nevertheless, openings formed in tissue membranes, such as arterialwalls, take time to heal.

Prior methods and devices typically involve placement of collagenexternal to the puncture wound with or without the placement of apolylactide member internal to the puncture wound such as in the lumenof the blood vessel. Potential problems with this approach involve theincrease in thrombosis that has been observed to follow placement of apermanent intravascular device, the known effects of collagen toactivate platelets and consequently induce thrombosis, and theoccurrence of a systemic autoimmune inflammatory response followingimplants of bulk collages

By way of background, other suturing and stitching devices and methodsare disclosed in the following patents: U.S. Pat. No. 5,037,433 to Wilket al., U.S. Pat. No. 4,957,498 to Caspari et al., U.S. Pat. No.4,836,205 to Barrett, U.S. Pat. No. 4,437,465 to Nomoto et al., and U.S.Pat. No. 4,898,155 to Ovil et al.

The present invention provides a suture-based method of closure whichcircumvents the need for placement of any large piece, such as a stent,within the blood vessel, avoiding attendant risks of thrombosis.Additionally, use of collagens can be avoided, reducing the risk ofthrombosis or of an inflammatory autoimmune reaction. The presentinvention provides these advantages while being usable in the context ofnoninvasive techniques, such as laparoscopy, cardiovascular procedures,or other procedures avoiding conventional cut down surgery, therebyproviding the benefits without the necessity for direct visualization ofthe opening in the tissue which is to be closed. Additionally, thepresent invention provides substantially reduced healing times formedical patients, reducing patient discomfort and risk and also reducinghospital and personnel costs associated with prolonged healing.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-13 sequentially illustrate one embodiment of the methodaccording to the present invention to place sutures in a tissuemembrane.

FIGS. 14 a-14 f sequentially illustrate one embodiment of the methodaccording to the present invention to span sutures across an opening ina tissue membrane.

FIG. 15 a illustrates a partially cutaway side view of one embodiment ofa needle advancing apparatus according to the present invention.

FIG. 15 b illustrates a side view of one needle of the apparatus of FIG.15 a shown in isolation.

FIG. 15 c is a cross-section looking in a distal direction as if takenalong lines 15 c-15 c of FIGS. 15 a and 16 collectively.

FIG. 15 d is a partial cross-sectional view of an alternative embodimentof a tubular member of assembly 51 within the sheath of apparatus 50.

FIG. 16 a illustrates a partially cutaway side view of one embodiment ofa suture retrieval assembly according to the present invention.

FIG. 16 b is a partially cut away side view of another embodiment of asuture retrieval assembly according to the present invention.

FIG. 16 c is a rear view of the proximal end of the assembly of FIG. 16b.

FIG. 17 a illustrates the present invention with the needle sheathDetracted, the needles in a deployed mode, and the distal end of theretrieval assembly in an expanded mode.

FIG. 17 b is a rear cutaway view of the suture magazine 60 of FIG. 17 ashowing the needle crank portions in phantom lines.

FIG. 17 c illustrates the present invention with the needle sheathadvanced, the needles in a compact mode, and the distal end of theretrieval assembly in a contracted mode.

FIG. 17 d is a rear cutaway view of the suture magazine 60 of FIG. 17 cshowing the needle crank portion in phantom lines.

FIGS. 18-22 illustrate alternative embodiments of the distal end of theretrieval assembly.

SUMMARY OF THE INVENTION

According to one embodiment, the present invention provides anonsurgical method for closure of an opening in a tissue membranebeneath the skin of a patient. The method includes the steps ofproviding a tubular member having a lumen therein beneath the skin ofthe patient and in close proximity to and preferably protruding throughthe opening; inserting a retrieval assembly through the lumen and pastthe opening to a location on a distal side of the tissue membrane;advancing needle means for passing sutures through the tissue membraneat separate suture locations around the opening; grabbing the sutureswith the retrieval assembly on the distal side of the tissue membrane;retrieving the sutures through the opening by withdrawing the retrievalassembly out through the opening; and, drawing together the suturelocation with the sutures.

According to another embodiment, the present invention provides anapparatus for passing sutures through a tissue membrane located beneaththe skin of a patient around an opening in the tissue membrane. Theapparatus includes a tubular body having a side wall defining a lumentherein. The tubular body allows introduction of material into thepatient through the lumen beyond the tissue membrane. The apparatusfurther includes an array of at least two needles disposed around thetubular body which carry a respective length of suture. The array ofneedles is advanceable through the tissue to a distal side thereof toprovide sutures at separate suture locations in the tissue membranearound the opening.

According to another embodiment, the present invention provides anapparatus for retrieving sutures, alone or in combination with thepreviously described apparatus, comprising a retrieval assembly havingan elongated portion having a end. The first end includes at least oneflexible bow having a distal end, a proximal end, and a central portiontherebetween. The apparatus further includes a tension member attachedto the distal end of the bow member. The tension member and the proximalend of the bow are selectively movable with respect to each other tourge the distal end and the proximal end towards each other and apartfrom each other, causing the central portion of the bow to deflectoutwardly away from the tension member to receive sutures, and todeflect inwardly toward the tension member in a collapsed position tosecure sutures at the first end. The first end in the collapsed positionis sized to be withdrawn through a catheter lumen.

One object of the present invention is to provide an improved apparatusand method for positive closure of a subcutaneous tissue membraneopening.

Another object of the present invention is to provide closure of tissuemembrane openings, such as punctures in blood vessels.

Another object of the present invention is to reduce the need for theuse of collagens and/or intravascular devices, such as stents, forclosure of puncture wounds.

A further object of the present invention is to reduce the clotting timeand the healing time required for a puncture wound in a tissue membrane.

These and other objects and advantages of the present invention will beapparent from the written description and drawing figures herein.

DESCRIPTION OF THE PREFERRED EMBODIMENT

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiment illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is thereby intended, such alterations and furthermodifications in the illustrated device and method, and such furtherapplications of the principles of the invention as illustrated thereinbeing contemplated as would normally occur to one skilled in the art towhich the invention relates.

The present invention provides for the closure of openings in tissuemembranes beneath the skin of a medical patient. The invention isuseful, for example, to close the opening in the wall of a blood vesselcaused by catheterization procedures. The invention is advantageous inthat it allows closure of such openings without the need to surgicallycut open the patient to visualize the closure procedure. In addition toclosure of openings in blood vessels, the invention is useful forclosing a variety of openings in various tissue membranes beneath theskin of a patient. Regarding the terminology herein, “distal” meanstoward the patient and away from the operator (doctor), and conversely“proximal” means toward the operator and away from the patient.

The general procedure of the invention begins with the placement of acatheter through the opening in the tissue membrane. A retrieval deviceis inserted through the catheter and beyond the opening to the distalside of the membrane. The distal end of the retrieval device is expandedand pulled tightly against the inside surface of the tissue membrane.Thereafter, one or more needles carrying sutures are inserted throughthe tissue membrane around the opening. The retrieval device grabs thesutures on the distal side of the membrane. The retrieval device is thencontracted and removed through the catheter, pulling the sutures withit. Thereafter, knots are formed in the sutures to draw the openingclosed for healing. The preferred embodiment of the present inventionhas two primary components, retrieval assembly 51 (see FIG. 16) andneedle advancing apparatus 50 (see FIG. 15 a). Collectively, these formthe suturing device 52.

Referring to FIGS. 1-13 and FIGS. 14 a-14 f, a representativeillustration of the present inventive method is illustrated for positiveclosure of opening 99 in tissue membrane 43 of blood vessel 42. Theblood vessel is located beneath the skin 40 of a medical patient, and isaccessed through opening 41 in the skin. Note that the side wall ofblood vessel 42 is illustrated partially cut away to facilitateillustration of the method, it being understood that ordinarily themethod is performed only with opening 99 in tissue membrane 43. Tissuemembrane 43 has a proximal side or surface 44 on the outside thereof andan Opposite distal side or surface 45 on the inside thereof asillustrated. While the represent invention is illustrated for repairingblood vessel 42, it is to be understood that the present invention mayhave applicability in positive closure of openings in other tissuemembranes in a medical patient which are located beneath the surface ofthe skin. Such openings may include openings caused by medicalprocedures, such as laparoscopy, angiography, and others, as well asopenings caused by traumatic wounds, including puncture wounds.

FIG. 1 illustrates blood vessel 42 having a sheath 56, such as acatheter, passing through opening 41 and opening 99 and into theinterior lumen of the blood vessel, beyond distal side 45. Sheath 56includes a side wall defining one or more lumens therein as is wellknown. Sheath 56 typically may be initially placed in blood vessel 42 tofacilitate introduction of material into the blood vessel, such as guidewires, catheters, scopes, dilators, inflatable balloons, or any othermedical appliance, as well as introduction and/or removal of fluids suchas blood, medication, and/or contrast media. In one application, thepresent inventive method is typically employed after such techniquesand/or procedures, referred to herein generally as catheterizationprocedures, are completed and such medical devices have been removedfrom sheath 56.

Needle advancing apparatus 50 is illustrated in FIG. 1 disposed aroundthe outside of the side wall of sheath 56, and slideable longitudinallyalong the length thereof. Apparatus 50 is described in greater detailbelow. Apparatus 50 includes a tubular member 62 having a side walldefining a lumen therein with an array of needles disposed around sheath56 protected by a needle guard 55. The needles each have respectivelengths of sutures attached thereto.

The distal end 53 of retrieval assembly 51 is inserted (FIG. 2) into theproximal end of the lumen of sheath 56. Retrieval device 51 is fullyinserted into sheath 56 (FIG. 3) to position the distal end 53 beyondthe distal end of sheath 56 and on the distal side of the membrane 43.The distal end of the retrieval assembly is initially in a collapsedstate, being sized with a cross-sectional dimension to allow insertionand withdrawal of distal end 53 through the lumen of sheath 56.

Distal end 53 is then expanded within blood vessel 42 (FIG. 4) on thedistal side of membrane 43. The expanded state in this embodiment isformed by a plurality of bows, such as bow member 54, which are bulgedoutwardly. In this particular embodiment the configuration is analogousto an expandable bolt used to anchor fixtures to a building wall. Themechanics of this expansion are described more fully below, butgenerally are caused by manipulating two handle members at the proximalend of retrieval assembly 51, namely by rotational release ofspring-loaded and/or screw threaded handles, such as movement of handle75 with respect to handle 73 as shown by the arrow. The distal endpreferably includes an expandable outer member and an inner member whichrotates within the outer member.

Distal end 53 is expanded and urged against the distal side 45 of thetissue membrane (FIG. 5). Such urging is preferably accomplished bypulling on handle 73, which is connected to distal end 53, in thedirection of the-arrow. By urging the distal end against the distal sideof the tissue (e.g., against the inside of the blood vessel) the bloodvessel is distended somewhat and held relatively stationary tofacilitate insertion of the suture carrying needles through the tissuemembrane. A hemostasis seal member, such as boot 631 (see FIGS. 4 and 5)described further below, seals opening 99 against outflow of fluid suchas blood during the procedure.

Needle advancing apparatus 50 is advanced forwardly along sheath 56towards opening 99. It is slid far enough forward (i.e., distally) sothat needle guard 55 passes through opening 41 in the skin, with thedistal edge of the needle guard near opening 99 in the blood vessel (seeFIG. 6). In t position, the needle guard is poised to be withdrawn,exposing the needles in close proximity to opening 99.

The needle guard 55 is then withdrawn (FIG. 7) by sliding it along tubemember 62 (which surrounds sheath 56) to expose the suturing needles,such as needle 57. In the illustrated embodiment, apparatus 50 includesfour such needles arrayed equidistantly around sheath 56 for insertioninto the tissue membrane around opening 99. The needles are initially ina compact mode.

The needles, such as needle 57, are then moved radially outwardly (FIG.8) (not to scale) away from their relatively radially compact positionillustrated in FIG. 7. The manner of deployment in the preferredembodiment is described further below, but generally is caused by ninetydegree rotation of a suture magazine 60 with respect to tubular member62 as shown by the arrow. The needles are arranged as a crankingmechanism which, in response to rotation of magazine 60, causes theneedles to move radially outward. In this way, the needles are betterradially spaced to allow insertion in the tissue membrane around thecircumference of opening 99. It is to be understood that this crankmechanism is only one approach, and other approaches of radiallydeploying the needles may be utilized, such as spring biased needleswhich spring outwardly.

The needles, such as needle 57, are then advanced through the tissuemembrane (see FIG. 9). This is caused by forward (i.e. distal) movementof apparatus 50 along sheath 56. The needles are advanced through thetissue membrane at various suture locations caused by the puncturingaction of the needles: The needles carry suture or other suitablesurgical closure materials. In the preferred embodiment, each needle isa solid stylet with an eyelet near its distal tip carrying adoubled-back length of suture 58 (see FIG. 15 b). Accordingly, fourlengths of suture, each doubled back, are simultaneously advancedthrough the tissue membrane from proximal side 43 to distal side 45. Thesutures carried by the needles are preferably stored in four independentmagazine compartments within suture magazine 60. Not only is the sutureadvanced beyond distal wall 45 of the blood vessel, but furthermore, theneedles and their respective sutures are inserted interstitially betweenthe suture grabbing elements of distal end 53 of the retrieval device51.

Handle member 73 is attached to the proximal end of retrieval assembly51 and is rotated with respect to handle 71. This causes rotation ofdistal end 53 as shown by the arrows (FIG. 10). This rotating, in thepreferred embodiment, grabs the sutures carried by the needles. Thisgrabbing action along with the rotation may cause a suture to be pulledout of the magazine compartments (shown partially cutaway) in magazinechamber 60 as it is being drawn into the distal end of the retrievalassembly. A variety of mechanisms, rotational and nonrotational, may beused for this grabbing feature, it being understood that the embodimentillustrated and the embodiments described later are merely exemplary. Itshould be further noted that the grabbing action occurs beyond openingand occurs on the distal side 45 of the blood vessel wall.

Distal end 53 of the retrieval assembly is then collapsed to allowwithdrawal through the lumen of sheath 56 (see FIG. 11). Such collapsingmay be accomplished by a variety of mechanisms. In the preferredembodiment this is done by longitudinal movement of handle 75 towardshandle 73 as illustrated by the arrow in FIG. 11, collapsing the bows ofdistal end 53 into a cross-sectionally compact mode. In this mode, thesutures remain held by distal end 53. FIG. 12 illustrates retrievalassembly 51 completely withdrawn from apparatus 50. Such withdrawal isaccomplished by puking the retrieval assembly, including elongated tubemember 63 and distal end 53, out of the lumen of sheath 56. Since thesutures, such as suture 58, are still connected to distal end 53, thewithdrawal pulls the sutures out of magazine 60 distally through thesuture locations in the tissue membrane. The sutures are thereby doubledback and pulled outwardly through the lumen of sheath 56.

Apparatus 50 is thereafter withdrawn from opening 99 and opening 41 inthe patient, carrying the sutures outwardly through opening 41. FIG. 13illustrates needle guard 55 advanced forwardly, covering the tips of theneedles. Such movement of needle guard 55 forwardly is done prior towithdrawal of apparatus 50 and after the needles are retracted into aradially compact mode in a manner inverse to the steps described inconnection with FIGS. 6 and 7. Thereafter, apparatus 50 is removedentirely with the sutures being separated (by cutting or otherwise) sothat what remains are four lengths of suture (each doubled back)threaded through a respective four suture locations around opening 99 inthe blood vessel.

The foregoing method has been described with the simultaneous advancingfour needles and sutures through the tissue membrane. However, it is tobe understood that the present procedure may be done with more or lessneedles and sutures and/or be done with sequential advancing of needlesand suture through the tissue membrane. The foregoing method isadvantageous in that it may be performed “blind” inside of a patientbeneath the surface of the skin of the patient, without the necessityfor endoscopic or other viewing. The present invention may also beperformed with the assistance of endoscopic equipment in appropriatecircumstances. However, such threading operation through opening 41 inthe skin without a full cut-down opening of the skin to access and viewthe opening in the blood vessel or other membrane is extremelyadvantageous and does not require endoscopic viewing.

FIGS. 14 a through 14 f illustrate one example of a technique toposition the sutures as illustrated in FIG. 13 across opening 99 topositively draw the opening closed for healing. In FIGS. 14 a-14 f, onlytwo (rather than four) sutures are illustrated for purposes of drawingclarity and simplicity, it being understood that the same technique maybe repeated for the other sutures. FIG. 14 a illustrates suture 58 a andsuture 58 b which are typical surgical sutures (sterilized) which willeventually dissolve in the patient after the wound is healed. Suture 58a is doubled back to form loop 59 a at one end with free ends 61 a and62 a at the opposite end. Suture 58 a is threaded downwardly throughsuture location 157 a from the proximal side of the tissue membrane tothe distal side of the tissue membrane, and is doubled back out throughopening 99 in blood vessel 42. Similarly, suture 58 b is doubled back,forming loop 59 b and free ends 61 b and 62 b. Suture 58 b is threadedthrough suture location 157 b.

Free end 61 a is pulled through (see the bold arrow in FIG. 14 b) suturelocation 157 a and outwardly through openings 99 and 41 so that thesuture is no longer doubled back. Then, distal end 61 a is insertedthrough (see the bold arrow in FIG. 14 c) loop 59 b of the oppositesuture 58 b. Pulling (see the bold arrows) on both of free ends 61 b and62 b (FIG. 14 d) causes loop 59 b to be drawn downwardly, pulling suture58 a downwardly with it. Continued pulling on free ends 61 b and 62 bpulls loop 59 b upwardly through suture location 157 b (FIG. 14 e),pulling suture 58 a upwardly through suture location 157 b.

FIG. 14 f illustrates suture 58 a passing through the tissue membrane atsuture locations 157 a and 157 b, spanning diametrically across opening99. Thereafter, suture 58 a is drawn tight, such as by advancing or by“throwing” a suturing knot (e.g. an overhand knot) across opening 99,and positively drawing it closed. Such knot techniques and knot throwingmay be accomplished with the aid of a pusher to advance the suturingknot downwardly towards opening 99.

It is to be understood that the foregoing threading illustrated in FIGS.14 a-14 b is merely exemplary, and other techniques may be used,including techniques to provide a suture circumferentially aroundopening 99 in a purse string configuration. After opening 99 is drawnclosed, opening 41 is closed in the conventional manner and the patientis allowed to heal.

FIGS. 15 a-17 d illustrate in greater detail the needle advancingapparatus 50 and the retrieval assembly 51 previously described Sheath56 forms a central core of apparatus 50. Sheath 56 comprises a side walldefining a central lumen 56 a passing all the way through assembly 50.Although as illustrated sheath 56 has a single lumen, it is contemplatedthat the present invention may be utilized with a multi-lumen sheathand/or device having endoscopic capabilities. Sheath 56 has housing 56 dforming a chamber therein mounted at its proximal end. Housing 56 d hasa seal 56 b mounted therein. This seal may be a variety of designs, butpreferably is an elastomeric gasket body, such as silicone rubber,having slits and/or other openings therein to allow selective insertionand removal of medical instruments, such as guide wires, catheters andother such devices, while maintaining a fluid tight seal therearound. IDthis way, blood or other bodily fluid is prevented from leaking out, andu wanted air is prevented from entering into the body.

Housing 56 d further has a side port (optional) 56 e which ordinarilywill have a stop-cock or other closure mechanism (not shown). In thisway, catheter 56 may act as a hemostasis cannula to remain indwelling inthe blood vessel 42 throughout the prior medical procedure.

Apparatus 50 further includes a tubular member 62 surrounding sheath 56and providing a housing for holding the four needles, such as needle 57.Needle 57 is shown in isolation in FIG. 15 b and includes needle tip 57a at its distal end, a proximal portion 57 b, and a central portion 57 ctherebetween. Central portion 57 c defines a longitudinal axis ofrotation. Proximal portion 57 b is connected to the central portion bycrank portion 57 e. Similarly, the needle tip is eccentric to the axisdefined by central portion 57 c since it is connected to the centralportion by crank portion 57 d. As illustrated in FIG. 15 a, needle 57 ismounted with the central portion 57 c rotationally movable withintubular member 62, and with proximal portion 57 b mounted in threadmagazine 60. Thread magazine 60 is rotationally movable over a ninetydegree arc with respect to tubular member 62, and such movement causes acranking action of needle 57 ranging from fully compact to fullydeployed, optionally with locks in each position. Such cranking actioncauses rotation of the central portion 57 c which, in turn, causescranking or swinging of crank portion 57 d and needle tip 57 a inwardlyand outwardly with respect to sheath 56. In this way, with needle guard55 withdrawn as illustrated in FIG. 15 a, needle tip 57 a, along withthe needle tips of the other three needles, is cranked to swing radiallyinwardly and outwardly with respect to sheath 56 to allow positioning ofthe needles for insertion through the tissue membrane around the hole.Such cranking action is illustrated comparatively between FIG. 17 a andFIG. 17 c, and between FIGS. 17 b and 17 d. FIG. 15 c illustrates across sectional view, looking distally, through apparatus 50 andassembly 51 with the needles in a compact mode.

Suture 58 is housed in suture chamber 65 within suture magazine 60. InFIG. 15 a, the remaining suture magazines are shown empty forillustration purposes, it being understood that in operation eachcarries suture for its respective needle. Suture chamber 65 includes apair of suture openings 66 through which the suture is pulled as thesuture is advanced through the tissue membrane of the patient. Thesuture passes between sheath 56 and tubular member 62 and is carriedthrough an eyelet at the tip of its respective needle. Alternativeneedle constructions may also be used, such as a hollow needle cannulacarrying suture downwardly through the center of the cannula and doubledback on the outside of the cannula away from the cutting edge.

The needle assembly and member 62, along with the needle magazine 60,may be modified to allow placement around sheath 56 even after sheath 56is in place in the patient, as an option to the illustrated version inwhich tubular member 62 is positioned around sheath 56 prior toinsertion of sheath 56. For example, member 62 may be longitudinallysplit and provided as two mating parts, such as a clam shell, around theoutside of sheath 56 (not shown).

FIG. 16 a illustrates a partially cutaway side view of retrievalassembly 51. Retrieval assembly 51 has a handle assembly on the proximalside thereof opposite of distal member 53, with elongated tubular member63 therebetween. Elongated tubular member 63 may comprise a catheterhaving a wire or other tension member 80 disposed in its central lumen.Distal end 53 has a plurality of inner bows and outer bows such as bow54. These-bows are formed in one embodiment by slits in the wall oftubular member 63 a (outer bow) and slits in the wall of tubular member63 b (inner bows). Each bow has a distal end 53 d, a proximal end 53 p,and a central portion 53 c therebetween. Tension member 80 is attachedto the distal end 53 d by connection 80 a. As illustrated, each innerbow may have serrations along its inside edge. When tension member 80 ispulled towards the proximal end of assembly 51, it draws the distal endsof the bows toward the proximal ends of the bows, causing the centralportions to bulge outwardly in a radial direction. Such bulging isillustrated by comparing FIG. 17 c (end 53 in a contracted position)with FIG. 17 a (end 53 in an expanded position). In the expandedposition, serrations on the inner bows are exposed to help grab thesutures.

Movement of tension member 80 with respect to elongated tubular body 63may be accomplished in a variety of ways, one of which is illustrated inFIG. 16 a. Specifically, handle 75 is moved longitudinally with respectto handle 71 and handle 73 to cause such relative movement. Handle 75 ismounted and slidable longitudinally within handle 73. Handle 75 is urgedaxially away from handle 73 by compression spring 77. Handle 75 isconnected to tension member 80, whereas handle 73 is connected toelongated member 63 b. Pin 76 a secured to handle 75 is slidable withinz-shaped slot 76 b in handle 73. In this way, relative movement betweenthe handles is at a predetermined and controlled distance with apositive locking feature. Furthermore, handle 73 is rotatable withinhandle 71. Specifically, handle 73 includes a circumferential groove 72b which rides around radially inward detent 72 a, allowing radialrotation but not allowing axial movement between handles 73 and 71. Suchrotation is further controlled and limited by pin 74 a abutting stopmember 74 b. The rotational position of distal end 53 is thereby limitedand is indexed at a known position. By maintaining handle 71 stationarythe outer bows of tubular member 63 a (affixed, thereto) are maintainedstationary; whereas rotation of handle 73 within handle 71 cause theinner bows of tubular member 63 b to rotate inside of the stationary,outer bows. The rotating inner bows have serrations which grab thesuture while the outer bows remain stationary to shield surroundingtissue from abrasion or other damage.

Through visual indexing markings, or actual physical forced alignment,the relative axial position between the bows of distal end 53 ofretrieval assembly 51 may be predetermined with respect to the needles57 of assembly 50. As a result, when the needles are advanced throughthe tissue membrane, the operator may ensure that the bows are placed toallow interstitial insertion of the needles between the outer bows. Itis contemplated that this indexing mechanism may be facilitated byproviding apparatus 50 in a sterilized hit with retrieval assembly 51.For example, tubular member 63 and sheath may be modified as illustratedin FIG. 15 d with tubular member 763 having a longitudinal outer rib763R which slides in a corresponding longitudinal inner groove in sheath756. A mating interaction may be provided between retrieval assembly 51and apparatus 50, such as by mating interaction between the distal endof handle 71 and housing 56 d to maintain alignment of the needles andthe bows.

FIGS. 16 b and 16 c illustrate an alternative embodiment of theretrieval assembly of the present invention. The structure noted byreference characters are similar to those used in connection with FIG.16 a except that a “1” or “2” is set forth in the hundredths digit ofthe corresponding reference character. For example, the handle 175 as inFIGS. 16 b and 16 c is analogous to handle 75 in FIG. 16 a. Theretrieval assembly has three key components, handle 171, handle 173 andhandle 175. Handle 171 is affixed to tubular member 63 a; handle 173 isaffixed to tubular member 263 b; and, handle 175 is affixed to tensionmember 80.

Handle 175 moves rearwardly (proximally) with respect to handle 171,thereby causing tension member 80 to be pulled in tension rearwardly(proximally) with respect to tubular member 63 a. Such rearward movementis actuated by withdrawing pin 276 a from recess 276 b, such as byradially inward movement of the lever to which pin 276 a is attached.Such withdrawal of the pin from the recess causes handle 175 to moverearwardly due to the forces acted upon by it by compression spring 177b. Pin 176 a of handle 175 rides in longitudinal slot 176 b of handle171 to maintain alignment and to restrict relative travel distance.Tension is thereby exerted on tension member 80, causing the distal endof the retrieval assembly to expand as described in connection with FIG.16 a. Movement of handle 175 forward causes the distal end to collapseto allow passage through sheath 56.

Handle 173 is first advanced and then rotated. Handle 173 islongitudinally movable with respect to handle 171, thereby causinglongitudinal movement of tubular member 263 b with respect to tubularmember 63 a. Handle 173 may be advanced forwardly (distally) with pin172 a riding in longitudinal slot 172 c overcoming the bias ofcompression spring 177 a causing extension of tubular member 263 b.Handle 173 is rotatable with respect to handle 171, causing tubularmember 263 b to rotate with respect to tubular member 63 a. Rotationoccurs with pin 172 a riding in circumferential groove 172 b. Rotationof handle 173 and the resulting rotation of tubular member 263 b causesrotation of the snagging mechanism within the bows of the distal end ofthe retrieval assembly. Longitudinal withdrawal of tubular member 263 bcauses withdrawal of the snagging mechanism at the distal end of theassembly, such as described further in connection with FIGS. 19 and 20below.

FIGS. 17 a-17 d provide schematic comparisons of the moving parts of thepresent invention in different positions. For example, FIG. 17 a andFIG. 17 b show needle guard 55 retracted or withdrawn, with needles 57in a radially expanded mode and with distal end 53 of the retrievalassembly like wise in an expanded mode. Needle guard 55 includes handle55 a attached thereto to facilitate manual sliding along the outside oftubular member 62. Conversely, FIG. 17 c and FIG. 17 d illustrate needleguard 55 advanced in a sheathed position with the needles 57 in aradially retracted position and with a distal end 53 of the retrievalassembly likewise in a contracted position. Comparison between FIGS. 17b and 17 d illustrates the cranking action of cranking portion 57 e ofthe needles. Note further that these two figures illustrate sutures indual coils in all four chambers of the suture magazine.

FIG. 18 shows distal end 153 with outer bow 153 a and inner serrated bow154. Serrated bow 154 is formed from slits in flexible tubular member 63b having at least one serrated edge along each bow, as illustrated.Serrated bow 154 deflects outwardly similarly to the action of bow 153 awhen tension member 80 is pulled proximally with respect to elongatedmember 63 a. In such expanded state, end 153 comprises four inner bowswithin four outer bows. The inner bows rotate as previously describedwith respect to the stationary outer bows. A 7 sealing member, such aselastomeric boot 631, preferably is provided at the proximal base of theouter bows. This seal 631 functions to seal the opening which is beingclosed during the procedure so fluid, such as blood, is prevented fromflowing out. Seal 631 expands as the bows are expanded sufficiently toseal the opening.

Referring to FIG. 19, an alternative embodiment of the distal end of theretrieval device is shown as distal end 253, with one of the bowspartially. cutaway for drawing clarity. The bows, such as 253 a, areformed from slits in elongated tube 63 a which surrounds tension member80. Bow 253 a includes distal end 253 d, proximal end 253 p and centralportion 253 c. Two serrated members, such as serrated member 254, arerigidly attached to a collar 263 b, which is an end of tubular member263 b described in connection with FIG. 16 b above, and which is mountedover tension member 80. Rotation of the collar/tubular member 263 b andserrated member 254 within fixed distal end 253 causes snagging andgrabbing of sutures which are attached to the needles (previouslydescribed) positioned interstitially between the bows. Seal 631 isprovided and functions as described above. Pulling on tension member 80and its end piece 80 a cause the bows to expand. Collar 263 b may be aportion of an elongated tube which is axially movable to retractserrated members 254 with-in the outer bows as described with FIG. 16 b.

As a further alternative, FIG. 20 illustrates distal end 353 with bow353 a surrounding prong 354. As illustrated, other prongs (shown inphantom lines) are mounted over tension member 80 to grab and snagsuture. Note that optionally, instead of a boot 631 providing a seal,the bow configuration is altered to provide a frustoconical sealingsurface around the base of the outer bows. As with the device of FIG.19, tubular member 263 b may be rotated and retracted to withdraw prongs354 into a collapsed state.

FIG. 21 illustrates yet another embodiment, in which distal end 453includes a plurality of bows, such as bow 453 a, formed in an outersheath 63 a. Sheath 63 a is mounted around elongated member 463 a whichin turn is mounted around tension member 80. Inside the outer bows is asecond set of bows, such as bow 454. These inner bows 454 may be of ahook fabric material, such as Velcro® material. Such hook material maybe used in connection with multi-filament and/or monofilament suturematerial which acts as nap material to snag on the hook material of bow454 as bows 454 are rotated within the outer bows. A seal may optionallybe added.

As stated, other approaches to grasping the suture material on thedistal side of the membrane to be closed may be provided. FIG. 22illustrates distal end 553 with a membrane 554 of an elastomericmaterial, such as latex rubber, stretched around the outside of theexpandable bows of member 63 a and/or as part of a balloon. It has beenfound that when the interstitial needles penetrate through such latexrubber with the suture, the suture remains in place in the latex, evenupon removal of the needles. A rotational inner member is typically notrequired, although optionally may be provided Membrane 554 also acts asa hemostasis seal.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly the preferred embodiment has been shown and described and that allchanges and modifications that come within the spirit of the inventionare desired to be protected.

1. An apparatus for suturing a tissue membrane, the apparatuscomprising: a tubular body having a proximal portion and a distalportion, the distal portion sized to be extendable through an openingformed in the tissue membrane caused by a catheterization procedure; atleast one hollow needle having a proximal end and a distal end and alumen extending therethrough, wherein the distal end has a sharpenedpoint to puncture the tissue membrane, the hollow needle advanceable ina distal direction along the tubular body and through the tissuemembrane adjacent the opening in the tissue membrane; and at least onelength of suture, wherein a portion of the suture is disposed within thelumen of the hollow needle, wherein the hollow needle is configured tocarry the portion of the suture through the tissue membrane as thehollow needle is advanced distally.
 2. The apparatus of claim 1 furthercomprising a suture chamber defined in the proximal portion of thetubular body, the suture chamber holding at least a portion of thelength of suture, wherein the hollow needle carries at least a portionof the length of suture from the suture chamber through the tissuemembrane.
 3. The apparatus of claim 1 further comprising a sutureretrieval assembly at the distal portion of the tubular body anddeployable to receive the length of suture after the tubular body isextended through the opening in the tissue membrane.
 4. The apparatus ofclaim 1 further comprising a hemostasis seal member on the distalportion of the tubular body, the seal member being openable againstoutflow of fluid through the opening in the tissue membrane.
 5. Theapparatus of claim 1 wherein the suture disposed through the lumen ofthe hollow needle is doubled back along an outer surface of the hollowneedle.
 6. The apparatus of claim 5, wherein a distal end of the hollowneedle includes a cutting edge.
 7. An apparatus for suturing a tissuemembrane, the apparatus comprising: a tubular body having a proximalportion and a distal portion, the distal portion extendable through anopening in the tissue membrane caused by a catheterization procedure; atleast one hollow needle having a proximal end and a distal end and alumen extending therethrough, the hollow needle configured to beadvanceable in a distal direction along the tubular body and through thetissue membrane adjacent the opening in the tissue membrane, wherein thehollow needle is configured to puncture the tissue membrane; at leastone length of suture, wherein a portion of the suture is disposed withinthe lumen of the hollow needle, wherein the hollow needle is configuredto carry the portion of the suture through the tissue membrane as thehollow needle is advanced distally; and a hemostasis seal member on thedistal portion of the tubular body, the seal member being openableagainst outflow of fluid through the opening in the tissue membrane. 8.The apparatus of claim 7 further comprising a suture chamber defined inthe proximal portion of the tubular body, the suture chamber holding thelength of suture, wherein the hollow needle carries at least a portionof the length of suture from the suture chamber through the tissuemembrane.
 9. The apparatus of claim 8 further comprising a sutureretrieval assembly at the distal portion of the tubular body anddeployable to receive the suture after the tubular body is extendedthrough the opening in the tissue membrane.
 10. An apparatus forsuturing a tissue membrane, the apparatus comprising: a tubular bodyhaving a proximal portion and a distal portion, the distal portion sizedto be extendable through an opening formed in the tissue membrane causedby a catheterization procedure; at least one hollow needle having aproximal end and a distal end and a lumen extending therethrough,wherein the distal end has a sharpened point to puncture the tissuemembrane, the hollow needle advanceable in a distal direction along thetubular body and through the tissue membrane adjacent the opening in thetissue membrane; at least one length of suture, wherein a portion of thesuture is disposed within the lumen of the hollow needle, wherein thehollow needle is configured to carry the portion of the suture throughthe tissue membrane as the hollow needle is advanced distally; and asuture chamber defined in the proximal portion of the tubular body, thesuture chamber holding at least a portion of the length of suture,wherein the hollow needle carries at least a portion of the length ofsuture from the suture chamber through the tissue membrane.